U.S. Food and Drug Administration issued a proposed rule to set forth requirements related to the content, format and FDA’s review and communications procedures for premarket tobacco product applications (PMTAs) as part of the agency’s continued commitment to its oversight of e-cigarettes and other tobacco products. When finalized, this proposed rule will help to ensure that PMTAs contain sufficient information for evaluation such as details regarding the physical aspects of a tobacco product and information on the product’s potential public health benefits and harms. It also would codify the procedures by which the agency would review PMTAs and establish the requirements for manufacturers to maintain records related to the legal marketing status of their tobacco products.
Under the PMTA pathway, manufacturers or importers must demonstrate to the agency, among other things, that marketing of the new tobacco product(s) would be appropriate for the protection of the public health. That statutory standard requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products. The agency’s evaluation also includes reviewing a tobacco product’s components, ingredients, additives, constituents, toxicological profile and health impact, as well as how the product is manufactured, packaged and labeled.
In addition to content and format requirements, the proposed rule would codify the general procedures the FDA would follow when evaluating PMTAs, including application acceptance, application filing and inspections. Additionally, the proposed rule would establish PMTA-related requirements for filing amendments to an application, the time for review, withdrawal of applications, changes in ownership, post-market reporting and maintenance of records, FDA communications with an applicant, FDA’s disclosure procedures and electronic submission requirements.
This proposed rule also explains how applicants may submit a supplemental PMTA or a resubmission, which would reduce the burden of submitting and reviewing a standard PMTA in certain situations. A supplemental PMTA could be submitted when an applicant is seeking authorization for a new tobacco product that is a modified version of a tobacco product for which they have already received a PMTA marketing order. In addition, an applicant could resubmit a PMTA when seeking to address application deficiencies following the issuance of a “No Marketing Order.”
The proposed rule also establishes certain recordkeeping requirements for manufacturers regarding the legal marketing status of certain tobacco products without a PMTA, such as documents showing that a tobacco product is not required to undergo premarket review (grandfathered) or has previously received premarket authorization.
The proposed rule will be open for public comments for 60 days through November 25, 2019. The agency recently published a final guidance for manufacturers submitting applications through the PMTA pathway for ENDS, such as e-cigarettes, “vape” products and the liquid nicotine and nicotine-containing e-liquids used with such products. The agency has also issued a proposed rule on Substantial Equivalence Reports and a Tobacco Product Master File Guidance, and has conducted public meetings and educational webinars describing, among other things, the statutory requirements for premarket applications. The FDA will continue efforts to provide resources for industry to comply with federal tobacco regulations through online information, meetings, webinars and guidance documents.
